Glossary

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  • CTABefore a clinical trial can start, the sponsor must apply for and be given clinical trial authorisation (CTA). Each European country has its own regulatory authority that assesses applications for clinical trial authorisations. For clinical trials that will take place in more than one European(...)
  • ClinicalTrials.govClinicalTrials.gov is an online resource that provides information about clinical studies on a wide range of diseases. It includes information on whether the studies are recruiting patients, and a summary of the results of studies once they have finished. The resource can be found at(...)
  • Clinician-reported outcomeA type of outcome assessment determined by a trained health-care professional after observation of a patient’s health condition.
  • ClinROA type of outcome assessment determined by a trained health-care professional after observation of a patient’s health condition.
  • Cohort StudiesCohort studies are used to study how common diseases are, their causes, and their prognoses. Cohorts are groups of people who are selected on the basis of certain characteristics. For example, if exposure to a risk factor such as cigarette smoke is suspected to cause a disease, a cohort can be(...)
  • Cold-chainAn uninterrupted series of production, storage, and distribution activities, along with associated equipment and logistics, which maintain a desired low temperature range. It is necessary to maintain the quality and efficacy of certain medicines and vaccines.
  • College ter Beoordeling van GeneesmiddelenDutch National Competent Authority (English: MEB). http://www.cbg-meb.nl/"
  • CBGDutch National Competent Authority (English: MEB). http://www.cbg-meb.nl/"
  • Combined advanced-therapy medicinesCombined advanced-therapy medicines are medical products based on the combination of genes (gene therapy), cell therapy (cell therapy) or tissues (tissue engineering) with one or more medical devices as an integral part of the medicine.
  • Commissie Tegemoetkoming GeneesmiddelenBelgian Health Technology Assessment body. http://www.riziv.fgov.be/nl/riziv/organen/Paginas/commissie-tegemoetkoming-geneesmiddelen.aspx#.V1rMphM4ViQ"

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